Regulatory Essentials in Health Tech – Session 11: Clinical Evaluation in Practice


This session presents the essentials of clinical evaluation, including the requirements and guidelines for clinical evaluation as well as the structure of Clinical Evaluation plan and report. From the perspective of in vitro diagnostics, Performance Evaluation is reviewed as well.
Clinical Evaluation for medical device software is also briefed as well as conducting a literature report.

The Regulatory Essentials in Health Tech training series consists of 14 webinar sessions, 2,5h each.
Read more on the complete course page here.


 

SPRING 2022
Time: 5.5.2022 at 10.00-12.30 (EET)
Place: Online
Price: 250€ + VAT 24%

AUTUMN 2022
Time: 4.10.2022
Place: Online
Price: 250€ + VAT 24%

 

Target Group:
All health tech developers and stakeholders interested in gaining specific knowledge on how to apply Clinical Evaluation for medical devices. Special focus on start-up founders and staff, university innovator teams as well as young health tech professionals and new employees.

After this session, you:

  • Understand what are the fundamental requirements for Clinical Evaluation of medical devices and Perfomance Evaluation of in vitro diagnostics
  • Understand the relationship of Clinical Evaluation to Risk Management and Post-Market Surveillance

Notice:
This session is intended to provide the basic understanding on Clinical Evaluation of medical devices. It is recommended to follow the Regulatory Essentials sessions 1-4 as well as the session 7 (Risk Management) prior to this course.

Trainer:


Ilona:
”I have worked in regulatory compliance positions for 15 years. Prior to stepping into the Medical Device field, I held responsibilities in consumer electronics and environmental and material compliance and continue to advise manufacturers on those topics. For the past seven years, I have been guiding various health tech companies with Medical Device regulations. My experience ranges from the compliance of artificial intelligence (AI) medical software to hands-on clinical evaluation, and from setting up and auditing ISO 13485 compliant quality management systems to enabling the international market access for several types of health technology.”

CONTENT OF THIS SESSION:

    • Purpose of Clinical Evaluation
    • Requirements and guidelines
    • Structure of Clinical Evaluation plan and report
    • Claims and clinical benefits of your device
    • Establishing “state of the art”
    • Gathering and assessing clinical data
    • Clinical Evaluation for medical device software
    • Conducting and documenting literature and database searches

BILLING AND CANCELLATION POLICY 
Participation in the training can be cancelled two weeks (14 days) before the event free of charge. For cancellations made after this, we will charge 50% of the participation fee, except for cancellations made one week before the event, we will charge a 100% participation fee.

Cancellations are always made in writing to: koulutus@labquality.fi.  
The participating organization may, if it wishes, change the participant free of charge by notifying it in writing before the event to: koulutus@labquality.fi. The participation fee will be invoiced immediately after the event. The training session will be confirmed to the participant by e-mail about a week before the event.  Labquality reserves the right to cancel the training session due to a small number of participants.

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